MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	29711
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the balloon became stuck with the rotawire.The 85% stenosed target lesion was located in the non tortuous and non calcified perineal artery.A 2.5mmx150mmx150cm coyote and a 330cm rotawire and wireclip torquer were selected for use.During the procedure, the balloon was inflated at nominal pressure and it was noted that the balloon became stuck with the rotawire.Both balloon and rotawire were removed together as one unit with no issues and the procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that the balloon became stuck with the rotawire.The 85% stenosed target lesion was located in the non tortuous and non calcified perineal artery.A 2.5mmx150mmx150cm coyote and a 330cm rotawire and wireclip torquer were selected for use.During the procedure, the balloon was inflated at nominal pressure and it was noted that the balloon became stuck with the rotawire.Both balloon and rotawire were removed together as one unit with no issues and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Microscopic and visual inspection of the wire found no damages or defects.The rotawire was able to be removed but was not able to be reinserted due to damages to the coyote otw device.Dimensional inspection revealed the components were within specification.
Event or Problem Description
It was reported that the balloon became stuck with the rotawire.The 85% stenosed target lesion was located in the non tortuous and non calcified perineal artery.A 2.5mmx150mmx150cm coyote balloon and a 330cm rotawire guidewire were selected for use.During the procedure, the balloon was inflated at nominal pressure and it was noted that the balloon became stuck with the rotawire.Both balloon and rotawire were removed together as one unit with no issues and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Microscopic and visual inspection of the wire found no damages or defects.The rotawire was able to be removed but was not able to be reinserted due to damages to the coyote otw device.Dimensional inspection revealed the components were within specification.Correction to field d1: brand name from rotawire and wireclip torquer to peripheral rotawire and wireclip torquer.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13534780
• Report Number: 2134265-2022-01645
• Device Sequence Number: 11810809
• Product Code: MCW
• UDI-Device Identifier: 08714729838890
• UDI-Public: 08714729838890
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: 29711
• Device Catalogue Number: 29711
• Device Lot Number: 0028248501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 03/02/2022; 04/11/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/24/2022; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female